Derived label
Device software or design
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Assignment summary
- Mode key
- device_software_design
- Evidence excerpt
- software when using the Echo Module of ISCV, the issue
- Rule explanation
- Device recall wording explicitly identifies a software, firmware, programming, cybersecurity, or design defect and its failure or consequence.